FDA 483 - Yung Shin Pharmaceutical Industry Co., Ltd. - October 22, 2019

Yung Shin Pharmaceutical Industry Co., Ltd. in Tachia, Taichung, Taiwan, was inspected and cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed issues with process control monitoring, adherence to cleaning procedures, aseptic processing, disinfectant efficacy, laboratory controls, and incomplete master production records. These observations indicate a lack of robust quality systems necessary to ensure drug product quality and sterility.